UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049357 |
|---|---|
| Receipt number | R000056211 |
| Scientific Title | Encouragement for junior high school students to increase vegetable intake using an equipment to measure skin carotenoid levels -long term follow-up study- |
| Date of disclosure of the study information | 2022/10/31 |
| Last modified on | 2025/04/30 16:02:10 |
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Basic information
Public title
Encouragement for junior high school students to increase vegetable intake using an equipment to measure skin carotenoid levels -long term follow-up study-
Acronym
Long term study on the increase in vegetable intake
Scientific Title
Encouragement for junior high school students to increase vegetable intake using an equipment to measure skin carotenoid levels -long term follow-up study-
Scientific Title:Acronym
Long term study on the increase in vegetable intake using the measurement of skin carotenoid levels
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the efficacy of the dietary education using Veggie Meter that quantifies skin carotenoid levels
Basic objectives2
Others
Basic objectives -Others
To investigate the vegetable intake one year after dietary education using Veggie Meter
Trial characteristics_1
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Skin carotenoid level
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
dietary education
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 12 | years-old | <= |
Age-upper limit
| 16 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Students are enrolled in this study when the parents agree to participate in this study and submit signed consent form.
Key exclusion criteria
none
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Akira |
| Middle name | |
| Last name | Obana |
Organization
Seirei Hamamatsu General Hospital
Division name
Department of Ophthalmology
Zip code
430-8558
Address
2-12-12 Sumiyoshi, Naka-ku, Hamamatsu City, Shizuoka
TEL
0534742222
obana@sis.seirei.or.jp
Public contact
Name of contact person
| 1st name | Mitsuo |
| Middle name | |
| Last name | Kimata |
Organization
Seirei Hamamatsu General Hospital
Division name
Clinical Research Center
Zip code
430-8558
Address
2-12-12 Sumiyoshi, Naka-ku, Hamamatsu City, Shizuoka
TEL
0534742222
Homepage URL
m-kimata@sis.seirei.or.jp
Sponsor or person
Institute
Department of Ophthalmology, Seirei Hamamatsu General Hospital
Institute
Department
Personal name
Funding Source
Organization
Health & Welfare department, Public Health Promotion Division, Hamamatsu City
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Tokoha University, Hamamatsu University School of Medicine
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Seirei Hamamatsu General Hospital
Address
2-12-12 Sumiyoshi, Naka-ku, Hamamatsu City, Shizuoka
Tel
0534742222
m-kimata@sis.seirei.or.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 10 | Month | 31 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
119
Results
The mean (SD) and median of Veggie scores were as follows:
1st measurement,394(118),380
2nd measurement,429(126),413
3rd measurement,431(132),413
4th measurement,427(137),416
Veggie scores of 2nd, 3rd and 4th measurements were significantly higher than the initial value.
High score was maintained until one year after the end of intervention.
Results date posted
| 2023 | Year | 05 | Month | 02 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2022 | Year | 10 | Month | 21 | Day |
Date of IRB
| 2022 | Year | 10 | Month | 24 | Day |
Anticipated trial start date
| 2022 | Year | 11 | Month | 10 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2024 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2024 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2025 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2022 | Year | 10 | Month | 28 | Day |
Last modified on
| 2025 | Year | 04 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056211
